Alka-Seltzer Original

One tablet contains 324mg acetylsalicylic acid (aspirin) Ph.Eur, 965mg citric acid Ph.Eur and 1744mg sodium hydrogen carbonate Ph.Eur. The active ingredients in water become sodium citrate 1296mg, sodium acetylsalicylate 364mg and sodium hydrogen carbonate 328mg.

Effervescent tablets for oral administration.

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For fast and effective symptomatic relief of headache with upset stomach, particularly when due to too much to eat or drink. Alka-Seltzer Original is especially effective when taken before bed and again in the morning.

Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness.

For mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains.

Symptomatic relief of influenza, feverishness, feverish colds.

Alka-Seltzer Original tablets must always be dissolved in a glass of water prior to oral administration. The tablets dissolve more quickly in warm water.

The dose in adults, elderly and children aged 16 years and over, is two tablets in water. The dose may be repeated every four hours, as required, with a maximum of four dosages in 24 hours. These dosages should not be continued for more than three days without consulting a physician. The stated dose must not be exceeded.

Do not give to children under 16 years, unless specifically indicated (e.g. for Kawasaki's disease).

Alka-Seltzer Original should not be administered to patients:

• with known hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to acetylsalicylic acid, other salicylates or substances with similar actions e.g non-steroidal anti-inflammatory drug.

• with known hypersensitivity to any of the other ingredients, refer to section 6.1.

• with active peptic ulceration or a history of peptic ulceration.

• with haemorrhagic diseases such as haemophilia.

• in the last trimester of pregnancy (see sections 4.4 and 4.6).

• receiving doses of methotrexate at 15mg/week or greater (see section 4.5).

Acetylsalicylic acid may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions in susceptible individuals.

Caution should be exercised in patients:

• whose renal or hepatic function is impaired

• with a history of gastrointestinal disorders

• in the first or second trimester of pregnancy or who are breast-feeding (see sections 4.3 and 4.6)

• taking anticoagulants (e.g. coumarin derivatives or heparin)

Aspirin can cause gout in patients with low uric acid excretion.

There is a possible association between aspirin and Reye's syndrome when given to children. Reye's syndrome is a very rare disease, which affects the brain, and liver, and can be fatal. For this reason aspirin should not be given to children aged under 16 unless specifically indicated (e.g. Kawasaki's disease).

Home medications should be considered only for minor or temporary ailments and should be used as directed. If symptoms persist or recur frequently, a physician should be consulted.

Due to its inhibitory effect on platelet aggregation aspirin may cause increased bleeding during and after surgery.

This medicinal product contains 477mg sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.

Alka-Seltzer Original may:

• Enhance the activity of anticoagulants, insulin and sulphonylurea hypoglycaemic agents.

• Enhance the activity of methotrexate and increase its toxicity (see section 4.3).

• Diminish the effects of uricosuric agents.

• Diminish the effects of diuretics.

• Potentiate the risk of gastro-intestinal bleeding during concomitant therapy with corticosteroids.

• Potentiate the effects and side-effects of other non-steroidal anti-inflammatory drugs.

• Enhance the plasma concentrations of digoxin.

• Enhance the effects of some anti-epileptics, such as sodium valproate and phenytoin.

• Interact with antihypertensive medicines.

• Increase the risk of bleeding with thrombolytics and other anti-platelet agents e.g. ticlopidine.

Decreased blood salicylate levels may occur when aspirin is taken concomitantly with glucocorticoids. There is a risk of salicylate overdose when glucocorticoids treatment is stopped.

At doses of 3g/day or more, aspirin may:

• Increase risk of ulcers and gastro-intestinal bleeding when taken with other NSAIDs.

• Decrease glomerular filtration when taken with diuretics.

• Decrease glomerular filtration and anti-hypertensive effect when taken with ACE inhibitors.

Although clinical and epidemiological evidence suggests the safety of acetylsalicylic acid for use in pregnancy, caution should be exercised when administered to pregnant patients.

Acetylsalicylic acid has the ability to alter platelet function and, therefore, there may be a risk of haemorrhage in infants whose mothers have consumed acetylsalicylic acid during pregnancy. The onset of labour may be delayed and the duration increased, with an increase in maternal blood loss. Therefore, analgesic doses should be avoided during the last trimester.

High doses of acetylsalicylic acid may result in closure of foetal ductus arteriosus in utero and possibly persistent pulmonary hypertension in the new born. Kernicterus may be a consequence of jaundice in neonates.

Administration of aspirin at doses greater than 300mg/day, shortly before birth can lead to intra-cranial haemorrhages, particularly in premature babies.

The intake of acetylsalicylic acid by breast-feeding patients should be avoided as there is a risk of Reye's syndrome. Regular use of high doses could impair platelet function and produce hypoprothrombinaemia in the infant if neonatal vitamin K stores are low.

When aspirin has been taken regularly or high doses have been taken then breast-feeding should be discontinued early.

None known.

Gastro-intestinal disorders have been reported for acetylsalicylic acid containing products e.g. nausea, diarrhoea, vomiting and gastro-intestinal bleeding which can lead to anaemia in some cases. Gastro-intestinal ulcers may develop, which may lead to haemorrhaging and perforation.

Rare cases of bronchospasm, asthmatic or hypersensitivity reactions have been reported for acetylsalicylic acid containing products.

Isolated cases of liver function disturbances and severe skin reactions have also been reported.

Due to the effect on platelet aggregation aspirin may be associated with an increased risk of bleeding.

Dizziness and tinnitus have also been reported but these side effects are more commonly indicative of an overdose.

Salicylates / Aspirin

Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.

Symptoms

Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.

A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.

Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.

Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.

Management

Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium hydrogen carbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium hydrogen carbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.

Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.

The therapeutic uses of Alka-Seltzer Original are based on the following pharmacological properties of the active ingredients. Acetylsalicylate has analgesic, anti-pyretic and anti-inflammatory properties. The buffer converts acetylsalicylic acid to sodium acetylsalicylate and promotes gastric emptying.

Acetylsalicylate is rapidly absorbed from the small intestine after oral ingestion of Alka-Seltzer Original and rapidly distributed to all body tissues. Peak plasma levels occur at approximately 20 minutes. Excretion is mainly renal.

None relevant.

Alka-Seltzer Original tablets contain no additional excipients.

None known.

Shelf life of the product as packaged for sale: 36 months.

Do not store above 25^oC. Store in the original package.

Primary packaging consists of laminated paper/polyethylene/aluminium foil with surlyn heat foil or a direct printed lamination of aluminium and surlyn heat seal.

Aluminium foil pouches, each containing two tablets. Available in pack sizes of 2, 8, 10, 12, 20 or 30 tablets.

The tablets should not be removed from the foil pouches until immediately before use.

If only one tablet from the foil pouch is used, the remaining one should be disposed of.

If a foil pouch is damaged and/or the tablets are powdery or discoloured, they should not be used. However, in the event that tablets are used, they are not harmful.

Alka-Seltzer Original must not be used after the expiry date.

Keep out of the reach of children.

Bayer plc

Consumer Care Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

PL 00010/0511

January 2008